title: Daytime systolic ambulatory blood pressure with a direct switch between candesartan monotherapy and the fixed-dose combination olmesartan/amlodipine in patients with uncontrolled essential hypertension (SEVICONTROL-1).
abstract: A direct switch of candesartan to the fixed-dose combination olmesartan/amlodipine in uncontrolled hypertension is a frequent clinical requirement but is not covered by current labeling. An open-label, prospective, single-arm phase IIIb study was performed in patients with 32 mg candesartan followed by olmesartan/amlodipine 40/10 mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6 mm Hg (P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7 mm Hg). The reduction in office BP was 9.4±18.4/4.0±9.6 mm Hg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90 mm Hg using office BP and <135/85 mm Hg using ambulatory BP measurement. There were 8 adverse events with a possible relation to study drug and 1 unrelated serious adverse events. In conclusion, patients with uncontrolled moderate arterial hypertension being treated using candesartan monotherapy achieve a further reduction of BP when switched directly to a fixed-dose combination of olmesartan 40 mg/amlodipine 10 mg.
authors.affiliation: Institut für Pharmakologie und präventive Medizin, Mahlow and Cloppenburg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Zemmrich
authors.forename: Stephan
authors.initials: S
authors.lastname: Lüders
authors.forename: Andrea
authors.initials: A
authors.lastname: Gansz
authors.forename: Claus-Dieter
authors.initials: CD
authors.lastname: Sturm
authors.forename: Rolf
authors.initials: R
authors.lastname: Fimmers
authors.forename: Jennifer
authors.initials: J
authors.lastname: Nadal
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
authors.forename: Joachim
authors.initials: J
authors.lastname: Schrader
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001713:Biphenyl Compounds; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002940:Circadian Rhythm / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013599:Systole / Q000187:drug effects / Q000502:physiology; D013777:Tetrazoles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D002121:Calcium Channel Blockers; D007093:Imidazoles; D013777:Tetrazoles; D017311:Amlodipine; C437965:olmesartan; C081643:candesartan